Drug Master Files for: KETOROLAC TROMETHAMINE
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KETOROLAC TROMETHAMINE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10372 | I | II | 11/2/1993 | SYNCHEM CHEMICALS PRIVATE LTD | KETOROLAC TROMETHAMINE |
10740 | I | II | 2/23/1994 | DELMAR CHEMICALS INC | KETOROLAC TROMETHAMINE |
11507 | I | II | 5/15/1995 | MAPRIMED SA | KETOROLAC TROMETHAMINE |
11688 | I | II | 9/29/1995 | DELMAR CHEMICALS INC | KETOROLAC DERIVATIVE |
11736 | I | II | 11/3/1995 | ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV | KETOROLAC TROMETHAMINE |
11799 | I | II | 1/4/1996 | CILAG AG | KETOROLAC TROMETHAMINE |
>DMF No. | >Status | >Type | >Submission Date | >Holder | >Subject |
Drug Master File Glossary
STATUS OF DMFS
- A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
- I = Inactive
- N = Not an assigned number
- P = DMF Pending Filing Review
TYPES OF DMFs
- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
- Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
- Type III Packaging Material
- Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
- Type V FDA Accepted Reference Information